FENILEFRINE AGUETTANT 100 micrograms/ml Injectable Solution and Perfusion Solution

2. What you need to know before you are given Phenylephrine Aguettant

Phenylephrine Aguettant will not be given to you:

• If you are allergic to phenylephrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• If you have extremely high blood pressure or peripheral vascular disease (poor circulation);
• If you are taking a monoamine oxidase inhibitor (MAOI) (or in the 2 weeks following its withdrawal), which is used to treat depression (such as iproniazid, nialamide);
• If you have an overactive thyroid gland (hyperthyroidism).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Phenylephrine Aguettant:

• If you are elderly;
• If you are diabetic;
• If you have high blood pressure;
• If you have an overactive thyroid gland (uncontrolled hyperthyroidism);
• If you have a disease of the blood vessels, such as arteriosclerosis (hardening and thickening of the walls of the blood vessels);
• If you have poor blood circulation in the brain;
• If you have an aneurysm;
• if you have heart disease, including chronic heart disease, peripheral vascular insufficiency, cardiac arrhythmias, tachycardia (rapid heart rate), bradycardia (slow heart rate), partial heart block, angina pectoris;
• If you have narrow-angle glaucoma (a rare eye disease).

In patients with severe heart failure, phenylephrine may worsen heart failure due to the constriction of blood vessels.

Your blood pressure will be monitored during treatment. If you have heart disease, additional monitoring of your vital functions will be performed.

Children

The use of this medicine is not recommended in children due to insufficient data on its efficacy, safety, and dosage recommendations.

Use of Phenylephrine Aguettant with other medicines

Tell your doctor if you are using, have recently used, or may need to use any other medicine, such as:

• certain antidepressants (iproniazid, nialamide, moclobemide, toloxatone, imipramine, milnacipran, or venlafaxine);
• medicines used to treat infections (linezolid);
• certain medicines used to treat migraines (dihydroergotamine, ergotamine, methylergonovine, methysergide);
• certain medicines used to treat Parkinson's disease (bromocriptine, lisuride, pergolide);
• a medicine used to inhibit the production of a hormone responsible for lactation (cabergoline);
• inhalation anesthesia (desflurane, enflurane, halothane, isoflurane, methoxyflurane, sevoflurane);
• medicines used as appetite suppressants (sibutramine);
• medicines used to treat high blood pressure (guanethidine);
• medicines used to treat heart failure and certain arrhythmias (cardiac glycosides);
• medicines used to treat abnormal heart rhythms (quinidine);
• medicines used during childbirth (oxytocin).

Pregnancy and breastfeeding

The safety of this medicine during pregnancy and breastfeeding has not been established, but the use of Phenylephrine Aguettant is possible during pregnancy if necessary.

The use of this medicine is not recommended during breastfeeding. However, breastfeeding is possible if it is administered only once during childbirth.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.

Driving and using machines

Talk to your doctor if you want to drive or use machines after using this medicine.

Phenylephrine Aguettant contains sodium

This medicine contains 78 mg of sodium (main component of cooking/table salt) in each 20 ml vial. This is equivalent to 4% of the maximum recommended daily sodium intake for an adult.

3. How Phenylephrine Aguettant is administered

Administration will be performed by a healthcare professional with the necessary training and experience, who will decide the correct dose for you and when and how the injection should be administered.

Recommended doses are:

Use in adults

Your doctor will determine the dose to be administered and may repeat or adjust it until the desired effect is achieved.

Use in patients with renal insufficiency(kidneys do not work well)

Lower doses of phenylephrine may be necessary in patients with renal insufficiency.

Use in patients with hepatic insufficiency(liver does not work well)

Patients with liver cirrhosis may require higher doses of phenylephrine.

Use in elderly patients

Treatment in elderly people should be carried out with caution.

Use in children

The use of this medicine is not recommended in children due to insufficient data on its efficacy, safety, and dosage recommendations.

If you have been given too much Phenylephrine Aguettant:

You may experience the following symptoms: palpitations, cardiac arrhythmias (tachycardia, cardiac arrhythmias), headache, nausea, vomiting, hallucinations, paranoid psychosis.

For more information about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious (frequency not known). Tell your doctor immediately if you experience any of these symptoms:

• chest pain or pain due to angina;
• irregular heartbeat;
• feeling of the heart beating out of the chest;
• brain hemorrhage (speech disorder, dizziness, paralysis of one side of the body);
• psychosis (loss of contact with reality);

Other side effects may include (frequency not known):

• hypersensitivity reaction (allergy);
• excessive dilation of the pupils;
• increased eye pressure (worsening of glaucoma);
• excitability (excessive sensitivity of an organ or part of the body);
• agitation (restlessness);
• anxiety;
• confusion;
• headache;
• nervousness;
• insomnia (difficulty falling asleep or staying asleep);
• tremors;
• tingling or prickling sensation of the skin (paresthesia);
• slow or fast heart rate;
• high blood pressure;
• breathing difficulties;
• fluid in the lungs;
• nausea;
• vomiting;
• sweating;
• pale skin (pale skin color);
• goosebumps;
• tissue damage at the injection site;
• muscle weakness;
• difficulty urinating or urinary retention.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Phenylephrine Aguettant

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the label after EXP. The expiration date is the last day of the month indicated. Your doctor or nurse will check this.

This medicine does not require any special storage temperature.

Keep the vial in the outer packaging to protect it from light.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Phenylephrine Aguettant

• The active ingredient is phenylephrine hydrochloride.

• Each ml of the injectable solution contains phenylephrine hydrochloride, equivalent to 100 micrograms (0.1 mg) of phenylephrine.
• Each 20 ml vial contains phenylephrine hydrochloride, equivalent to 2000 (2 mg) micrograms of phenylephrine.

• The other ingredients are sodium chloride, sodium citrate, citric acid monohydrate, sodium hydroxide, and water for injectable preparations.

Appearance of the product and pack contents

This medicine is a clear, colorless injectable solution in a 20 ml type II glass vial, closed with a rubber stopper and an aluminum cap.

The vials are available in packs of 1 and 10 vials.

Only certain pack sizes may be marketed.

Marketing authorization holder and manufacturer

LABORATOIRE AGUETTANT

1 rue Alexander Fleming

69007 Lyon

France

Local representative:

Aguettant Ibérica S.L.

Parc Científic de Barcelona

Baldiri Reixac, 4-8 (Torre I)

08028 Barcelona

Date of last revision of this package leaflet:December 2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/